510(k) K043041

AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) by Aesculap, Inc. — Product Code HCH

K043041 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX)". The FDA issued a decision of Substantially Equivalent on December 9, 2004. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2004
Date Received
November 4, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type